An interventional study of ICIT in Medical Unexplained Physical Symptoms (MUPS) and Subjective Health Complaint, sponsored by University of Oslo. Completed at 1 site in Norway. Open to participants aged 18 Years to 67 Years. Per ClinicalTrials.gov, last updated 2023-05-17.
Sponsored by University of Oslo · Not applicable, Interventional, and Supportive care
Many patients in general practice present symptoms that do not refer to specific pathology. We refer to these patients at Medical Unexplained Physical Symptoms (MUPS). Practice and research have well documented that these patients frustrate most General Practitioners (GPs). They also produce a lot of unnecessary investigations and are overrepresented on sick-listing. The conversational tool Individual Challenge Inventory Tool (ICIT) offers an aid for the GPS to the consultation and aims to increase the patients' coping abilities with their health challenges. The aim of the study is to investigate whether patients experience such increased coping following a session of consultations with their GP based on ICIT.
The study is a Cluster Randomized Controlled Trial (cRCT) with GPs as clusters. We plan to includ 50 GPs to participate as intervention group and 50 GPs as controls. Each cluster will include 10 patients. GPs in the intervention group will be trained in the use of ICIT through a 30 hours course, partly digital and partly in presence. The participants will receive lectures on the background for the conversation tool, and the study, and will practice on each other. At the end of the study, also the 50 GPs of the control group will be invited to an identical course.
The outcome of the study is any changes of the patients coping abilities. If the symptoms cannot be healed, a goal for the patients will be to reduce the impact of the symptoms. In practice, this is to reuptake normal activities, including work, in spite of pain, fatigue or mood disturbances. Through the ICIT, the patients will be challenged to look at themselves in a broader spectrum and decide for themselves which activities are possible to reuptake and making a thorough plan for doing so.
The patients will be treated by their regular GP across several meetings and they will agree on a specific plan across weeks or months to achieve their individual goal.
The patients of the GPs in the control group will represent identical medical symptoms and will be treated and followed by their GP as usual. They will, however, be informed and asked to consign to participate in the study, and will respond to the same questionnaires as the patients in the intervention group.
University of Oslo is the lead sponsor of 176 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
50 GPs will recruit 10 patients each from their daily practice, to take part in the study. They will offer the patients a session of unspecified length or number of consultations, to follow the conversation tool ICIT
Behavioral: ICIT
50 GPs will recruit 10 patients each from their daily practice, to take part in the study. They will however, only receive standard routine care and follow-up by their GP.
Patients in the intervention group will receive a number of consultations with their GP based on the ICIT
Patients' assessment of personal quality of life
Patients Global Impression of Change (PGIC)
Time frame: One year
Patients' experiences at the encounter
Mean change on score at the Patient Experiences Questionnaire (PEQ)
Time frame: One year
The primary outcome is any change in patient's coping strategies
Mean change on score at the Patient Activation Measure (PAM) in both groups
Time frame: One year
Single question
Patients will be asked about their own anticipation of return to work
Time frame: One year
Plan to share: No
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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University of Oslo